PHYSIOLOGICAL & BEHAVIORAL EFFECTS OF AMPHETAMINE AND COCAINE IN COMBINATION

本研究探讨了在可卡因使用者中使用兴奋剂药物作为替代疗法的安全性和可能的效用。具体来说，我们正在研究可卡因使用人群中可卡因和右旋安非他明之间的药物相互作用。这是一项人体实验室II期安全性研究，与III期临床试验一起进行，评估右旋安非他明处方将减少依赖患者可卡因滥用的假设。近期有可卡因滥用史的男性和女性受试者在服用两剂可卡因（安慰剂或96毫克鼻内）之前接受两剂右旋安非他明（安慰剂或30毫克）作为一小时的预处理。因此，该研究设计为安慰剂对照的2x2因子，检查每种药物单独使用和两种药物联合使用的效果。然而，人体安全问题要求受试者在联合用药之前先单独接受每种药物。这项研究已接近完成，但数据尚未被分析。然而，重要的是，我们的经验表明，没有临床上显著的副作用或心血管功能的改变，这表明至少中等剂量的右旋安非他明和可卡因可以安全地联合使用。研究结束后大约两个月将进行最后的数据分析，检查右旋安非他明是否会改变可卡因的滥用可能性。

This study examines the safety and possible utility of using stimulant medications as substitution therapy in cocaine users. Specifically, we are examining the drug interactions between cocaine and dextroamphetamine in a cocaine-using population. This is a Human Laboratory Phase II safety study being conducted in conjunction with Phase III Clinical Trials evaluating the hypothesis that dextroamphetamine prescription will reduce the abuse of cocaine in dependent patients. Male and female subjects with histories of recent cocaine abuse receive two doses of dextroamphetamine (placebo or 30 mg) as a one-hour pretreatment before one of two doses of cocaine (placebo or 96 mg intranasal). Therefore, the study design was a placebo-controlled 2x2 factorial examining the effects of each drug alone and the two in combination. However, human safety issues required that subjects receive each drug alone first, before the combination was administered. The study is nearly completed but the data have not yet been analyzed. However, important to the hypothesis has been our experience that no clinically significant side effects or alterations in cardiovascular functioning have occurred suggesting that at least moderate doses of dextroamphetamine and cocaine can be safely combined. Final data analysis examining whether dextroamphetamine altered the abuse potential of cocaine should proceed at study completion in approximately two months.